510(k) K200433 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
iBalance UKA Tibial Tray Implant
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Mar 17, 2020 |
| Received | Feb 21, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200433
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.